The purpose of this study is to compare the efficacy and safety/tolerability of indacaterol and glycopyrronium (QVA149) (fixed-dose combination) with fluticasone/salmeterol over a 26-week period in patients with moderate to severe COPD.

Forced Expiratory Volume in 1 Second Area Under the Curve (FEV1 AUC) 0-12 [ Time Frame: Week 26 ] [ Designated as safety issue: No ]

Forced Expiratory Volume in one second (FEV1) was calculated as the volume of air forcibly exhaled in one second as measured by a spirometer. FEV1 was normalized by 12 hours (divided by time). This outcome measures absolute values at week 26. Results are obtained from linear mixed model.

Standardized Forced Expiratory Volume in 1 Second (FEV1) was measured with spirometry conducted according to internationally accepted standards. Measurements were made between 0 and 12 hours after treatment. FEV1 was normalized by 12 hours (divided by time). This outcome measures absolute values at week 12. Results are obtained from linear mixed model.

Forced Vital Capacity (FVC) is the amount of air which can be forcibly exhaled from the lungs after taking the deepest breath possible. FVC was assessed via spirometry. A positive change from baseline in FVC indicates improvement in lung function.

Forced Vital Capacity (FVC) is the amount of air which can be forcibly exhaled from the lungs after taking the deepest breath possible. FVC was assessed via spirometry. A positive change from baseline in FVC indicates improvement in lung function.

Transition Dyspnea Index (TDI) captures changes from baseline. The TDI score is based on three domains with each domain scored from -3 (major deterioration) to +3 (major improvement), to give an overall score of -9 to +9, a negative score indicating a deterioration from baseline. A TDI focal score of 1 is considered to be a clinically significant improvement.

Total Score of the St. George's Respiratory Questionnaire (SGRQ-C) [ Time Frame: 12 weeks and 26 weeks ] [ Designated as safety issue: No ]

The total score of the St. George's Respiratory Questionnaire (SGRQ-C) is a health related quality of life questionnaire consisting of 51 items in three components: symptoms, activity, and impacts. The lowest possible value is zero and the highest 100. Higher values correspond to greater impairment in quality of life.

Mean Change From Baseline in Daily Number of Puffs of Rescue Medication [ Time Frame: Baseline, 12 weeks and 26 weeks ] [ Designated as safety issue: No ]

Participants maintained a diary to record the daily number of puffs of rescue medication used to treat COPD symptoms.

Change From Baseline in Symptom Scores Reported Using the Ediary [ Time Frame: 12 weeks and 26 weeks ] [ Designated as safety issue: No ]

After 12 weeks of treatment, Inspiratory Capacity (IC) was measured via spirometry, conducted according to internationally accepted standards. The mean of 3 acceptable measurements was calculated and reported in liters.

After 26 weeks of treatment, Inspiratory Capacity (IC) was measured via spirometry, conducted according to internationally accepted standards. The mean of 3 acceptable measurements was calculated and reported in liters.

Patients who have had a COPD exacerbation that required treatment with antibiotics, systemic steroids (oral or intravenous) or hospitalization in the last year.

Patients requiring long term oxygen therapy on a daily basis for chronic hypoxemia.

Patients who have had a respiratory tract infection within 4 weeks prior to Visit 1.

Patients with concomitant pulmonary disease

Patients with a history of asthma

Any patient with lung cancer or a history of lung cancer (within last 5 years)

Patients with a history of certain cardiovascular co-morbid conditions

Contacts and Locations

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Please refer to this study by its ClinicalTrials.gov identifier: NCT01315249